The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Kirwan Model 28 1000 Bipolar Coagulator.
| Device ID | K971341 |
| 510k Number | K971341 |
| Device Name: | KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DR. Marshfield, MA 02050 |
| Contact | Kevin Prario |
| Correspondent | Kevin Prario KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DR. Marshfield, MA 02050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1997-05-22 |
| Summary: | summary |